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NCT02219711 · ClinicalTrials.gov registry record · Phase 1
Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
A Phase 1 study of Advanced Cancer, sponsored by Mirati Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 193
- Enrollment target
- 20
- Study locations
NCT02219711 is a Phase 1 study of Advanced Cancer that has completed, run by Mirati Therapeutics. The registered enrollment target is 193 participants, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT02219711, a Phase 1 study of Advanced Cancer, has completed, sponsored by Mirati Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 193 participants
- Enrollment target
- 20
- Study locations
Study Summary
MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.
Conditions Studied
Interventions
- DRUG MGCD516
Study Locations (20)
California
- University of California, San Diego - San Diego
- University of California, San Francisco - San Francisco
- Sarcoma Oncology Research Center - Santa Monica
- Innovative Clinical Research Institute - Whittier
Florida
- Holy Cross Michael & Dianne Bienes Comprehensive Cancer Center - Fort Lauderdale
- Florida Cancer Affiliates - Ocala
- Florida Cancer Specialists - Sarasota
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Nebraska
- CHI Health St Francis, Saint Francis Cancer Treatment Center - Grand Island
- Oncology Hematology West PC, Nebraska Cancer Specialists - Omaha
Alabama
- University of Alabama - Birmingham
Colorado
- Rocky Mountain Cancer Center - Denver
Louisiana
- Ochsner Clinic Foundation - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2014-08 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02219711
The ClinicalTrials.gov registry entry for NCT02219711 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 245-participant average among 122 other Advanced Cancer trials with a reported enrollment target (21% lower). The listed sponsor is Mirati Therapeutics, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which MGCD516 is the first listed.
NCT02219711 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT02219711 about?
NCT02219711 is a clinical study titled "Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer". MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor ma...
What is the current status of trial NCT02219711?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 193 participants. The study started on 2014-08. Estimated completion is 2022-04-27.
What conditions does trial NCT02219711 study?
This clinical trial studies the following conditions: Advanced Cancer.
What interventions are being tested in trial NCT02219711?
The interventions under investigation include: MGCD516 (DRUG).
Who is sponsoring clinical trial NCT02219711?
This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02219711 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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